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FDA unveils preliminary list of NDAs for conversion to BLAs in 2020
9/26/2019

The Biologics Price Competition and Innovation Act of 2009 will trigger the conversion of various new drug applications into biologics license applications on March 23, 2020, because of the amended definition of biological products, which now includes proteins except those with any polypeptide that are chemically synthesized. The shift means all follow-on products associated with the NDAs will require approval as biosimilars.

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